Magnetic sphincter replacement device with internal seals

ABSTRACT

An apparatus is configured to be implanted within a biological lumen. The apparatus includes a plurality of magnetic elements and a coupling body. The magnetic elements are arranged in an annular array extending form an axis. The annular array defines an occludable opening configured to transition between an occluded state and an opened state. The magnetic elements include a first magnetic element and a second magnetic element. The second magnetic element is located adjacent to the first magnetic element. The second magnetic element includes a polymer magnetic material formed in a shape designed to geometrically interlock with the first magnetic element in the occluded state. The second magnetic element is configured to elastically deform to transition the occludable opening from the occluded state to the opened state. The coupling body is configured to affix to a portion of the first magnetic element and a portion of the second magnetic element.

FIELD OF THE INVENTION

The invention pertains to medical implants and insertion tools for suchimplants. More specifically, the invention pertains to implants andinsertion tools for a biological lumen and/or passageway.

BACKGROUND

In some instances, it may be desirable to place a medical implant withinor surrounding a biological lumen/passageway in order to improve orassist the function of, or otherwise affect, the biologicallumen/passageway. Examples of such biological lumens/passagewaysinclude, but are not limited to, the esophagus, a fallopian tube, aurethra, or a blood vessel. Some biological passages normally functionby expanding and contracting actively or passively to regulate the flowof solids, liquids, gasses, or a combination thereof. The ability of abiological passage to expand and contract may be compromised by defectsor disease. One merely illustrative example of a condition associatedwith decreased functionality of a body passage is Gastro EsophagealReflux Disease (or “GERD”), which effects the esophagus.

A normal, heathy, esophagus is a muscular tube that carries food fromthe mouth, through the chest cavity and into the upper part of thestomach. A small-valved opening in the esophagus, called the loweresophageal sphincter (or “LES”), regulates the passage of food from theesophagus into the stomach, as well as the passage of acidic fluids andfood from the stomach toward the esophagus. The LES may also regulatestomach intra-gastric pressures. A healthy LES may contain pressure ofgasses within the stomach at around 10 mm Hg greater than normalintragastrical pressure, thereby impeding acidic gases/fluids fromrefluxing from the stomach back into the esophagus. When functioningproperly, a pressure difference greater than 10 mm Hg may regulate whenthe LES opens to allow gasses to be vented from the stomach toward theesophagus.

If the LES relaxes, atrophies, or degrades for any reason, the LES maycease functioning properly. Therefore, the LES may fail to sufficientlycontain pressure of gasses within the stomach such that acidic contentsof the stomach may travel back into the esophagus, resulting in refluxsymptoms. Two primary components that control the LES are the intrinsicsmooth muscle of the distal esophagus wall and the skeletal muscle ofthe crural diaphragm or esophageal hiatus. A causation of esophagealreflux, which may be associated with GERD, is relaxation of one or bothof the smooth muscle of the distal esophagus wall or the hiataldiaphragm sphincter mechanisms. Chronic or excessive acid refluxexposure may cause esophageal damage. Conventionally, treatment for GERDmay involve either open or endoscopic surgical procedures. Someprocedures may include a fundoplication that mobilizes of the stomachrelative to the lower esophagus, or suturing a pleat of tissue betweenthe LES and the stomach to make the lower esophagus tighter.

Examples of devices and methods that have been developed to treatanatomical lumens by providing sphincter augmentation are described inU.S. Pat. No. 7,175,589, entitled “Methods and Devices for Luminal andSphincter Augmentation,” issued Feb. 13, 2007, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 7,695,427, entitled“Methods and Apparatus for Treating Body Tissue Sphincters and theLike,” issued Apr. 13, 2010, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 8,070,670, entitled “Methods and Devicesfor Luminal and Sphincter Augmentation,” issued Dec. 6, 2011, thedisclosure of which is incorporated by reference herein; and U.S. Pat.No. 8,734,475, entitled “Medical Implant with Floating Magnets,” issuedMay 27, 2014, the disclosure of which is incorporated by referenceherein.

While various kinds and types of lumen implants have been made and used,there is a continuing need in this art for novel implants, insertiontools, applicators, and instruments, and methods of using such implantsand instruments which provide improved patient outcomes and otherbenefits.

SUMMARY OF THE INVENTION

An apparatus is configured to be implanted within a biological lumen.The apparatus includes a plurality of magnetic elements and a couplingbody. The plurality of magnetic elements are arranged in an annulararray extending form an axis. The annular array defines an occludableopening configured to transition between an occluded state and an openedstate. The magnetic elements include a first magnetic element and asecond magnetic element. The second magnetic element is located adjacentto the first magnetic element. The second magnetic element includes apolymer magnetic material formed in a shape designed to geometricallyinterlock with the first magnetic element in the occluded state. Thesecond magnetic element is configured to elastically deform totransition the occludable opening from the occluded state to the openedstate. The coupling body is configured to affix to a portion of thefirst magnetic element and a portion of the second magnetic element.

An apparatus is configured to be implanted within a biologicalstructure. The apparatus includes a plurality of elastically deformablemagnets arranged in an annular array, a connecting structure, and aninert structure. The plurality of elastically deformable magnets definean occludable opening configured to transition between an occluded stateand an opened state. The elastically deformable magnets are magneticallybiased toward the occluded state. The connecting structure interconnectsthe elastically deformable magnets together to prevent each of theelastically deformable magnets from disconnecting from the rest of theelastically deformable magnets. The inert structure includes a coatingor extrusions of a polymer that is configured to limit erosion of theapparatus through the biological structure.

An apparatus is configured to be implanted within a biologicalstructure. The apparatus includes a plurality of magnetic elements and acoupling body. The magnetic elements are arranged in an annular arrayextending about an axis. The annular array defines an occludable openingconfigured to transition between occluded state and an opened state. Theplurality of magnetic elements are magnetically attracted toward theoccluded state. The coupling body is configured to affix to theplurality of magnetic elements. The coupling body is dimensioned to abutagainst the biological structure.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a cross-sectional side view, taken along a coronal planeof the body, of a biological passage;

FIG. 2 depicts a cross-sectional isometric view, taken along a coronalplane of the body, of a human esophago-gastric junction;

FIG. 3 depicts an isometric view of an exemplary artificial sphincterimplant that may be attached to an interior portion of a loweresophageal sphincter (LES) of the biological passage of FIG. 1;

FIG. 4A depicts a cross-sectional isometric view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 3 isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin an occluded configuration;

FIG. 4B depicts a cross-sectional isometric view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 3 isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin an opened configuration to accommodate passage of a bolus;

FIG. 4C depicts a cross-sectional isometric view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 3 isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin the occluded configuration after accommodating passage of the bolusof FIG. 4B;

FIG. 5 depicts an isometric view of a deployment assembly attached tothe artificial sphincter implant of FIG. 3, with the deployment assemblyin a pre-deployed configuration;

FIG. 6A depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted into anesophagus of the biological passage of FIG. 1, where the deploymentassembly and the artificial sphincter implant of FIG. 3 are in thepre-deployed position;

FIG. 6B depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted intothe esophagus of the biological passage of FIG. 1, where the deploymentassembly has expanded the artificial sphincter implant of FIG. 3 into afirst deployed position;

FIG. 6C depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted intothe esophagus of the biological passage of FIG. 1, where the deploymentassembly has expanded the artificial sphincter implant of FIG. 3 into asecond deployed position;

FIG. 7 depicts a cross-sectional isometric view, taken along a coronalplane of the body, of the artificial sphincter implant of FIG. 3attached to the esophagus of the biological passage of FIG. 1, where thedeployment assembly of FIG. 5 is removed from the artificial sphincterimplant, with a portion broken away to reveal internal components;

FIG. 8A depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted intothe esophagus of the biological passage of FIG. 1, where the deploymentassembly has expanded the artificial sphincter implant of FIG. 3 intothe first deployed position;

FIG. 8B depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted intothe esophagus of the biological passage of FIG. 1, where the deploymentassembly has expanded the artificial sphincter implant of FIG. 3 into aposition between the first deployed position and the second deployedposition;

FIG. 8C depicts a cross-sectional side view, taken along a coronal planeof the body, where the deployment assembly of FIG. 5 is inserted intothe esophagus of the biological passage of FIG. 1, where the deploymentassembly has expanded the artificial sphincter implant of FIG. 3 intothe second deployed position;

FIG. 9A depicts a cross-sectional side view, taken along a coronal planeof the body, immediately after the artificial sphincter implant of FIG.3 has been operatively attached to the interior portion of the LES ofthe biological passage of FIG. 1;

FIG. 9B depicts a cross-sectional side view, taken along a coronal planeof the body, after a sufficient period of time after the artificialsphincter implant of FIG. 3 has been operatively attached to theinterior portion of the LES of the biological passage of FIG. 1, suchthat there is minor tissue ingrowth around portions of the artificialsphincter implant;

FIG. 9C depicts a cross-sectional side view, taken along a coronal planeof the body, after a sufficient period of time after the artificialsphincter implant of FIG. 3 has been operatively attached to theinterior portion of the LES of FIG. 3 such that there is full tissueingrowth around portions of the artificial sphincter implant;

FIG. 10 depicts a cross-sectional top view of an exemplary alternativeartificial sphincter implant that may be attached to an interior portionof the LES of the biological passage of FIG. 1;

FIG. 11 depicts a cross-sectional top view of an overlapping magneticpetal of the artificial sphincter implant of FIG. 10;

FIG. 12A depicts a cross-sectional side view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 10 isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin an occluded configuration;

FIG. 12B depicts a cross-sectional isometric view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 10 isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin an opened configuration to accommodate passage of a bolus;

FIG. 13A depicts a cross-sectional top view of an exemplary alternativeartificial sphincter implant that may be attached to an interior portionof the LES of the biological passage of FIG. 1, where the artificialsphincter implant is in an opened configuration;

FIG. 13B depicts a cross-sectional top view of an exemplary alternativeartificial sphincter implant that may be attached to an interior portionof an LES of the biological passage of FIG. 1, where the artificialsphincter implant is in a partially opened configuration;

FIG. 14A depicts a cross-sectional side view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 13A isoperatively attached to the interior portion of the LES of thebiological passage of FIG. 1, where the artificial sphincter implant isin an occluded configuration;

FIG. 14B depicts a cross-sectional isometric view, taken along a coronalplane of the body, where the artificial sphincter implant of FIG. 13A isoperatively attached to the interior portion of the LES of FIG. 1, wherethe artificial sphincter implant is in the opened configuration toaccommodate passage of a bolus;

FIG. 15 depicts a top plan view of an exemplary alternative artificialsphincter implant that may be attached to an interior portion of the LESof the biological passage of FIG. 1;

FIG. 16 depicts a top plan view of an exemplary alternative artificialsphincter implant that may be attached to an interior portion of the LESof the biological passage of FIG. 1;

FIG. 17A depicts a cross-sectional perspective view of an annularretaining assembly of the artificial sphincter implant of FIG. 16 in anun-compressed configuration;

FIG. 17B depicts a cross-sectional perspective view of the annularretaining assembly of FIG. 17A in a compressed configuration;

FIG. 18A depicts a cross-sectional side view, taken along a coronalplane of the body, immediately after the artificial sphincter implant ofFIG. 16 has been operatively attached to the interior portion of the LESof the biological passage of FIG. 1; and

FIG. 18B depicts a cross-sectional side view, taken along a coronalplane of the body, after a sufficient period of time after theartificial sphincter implant of FIG. 16 has been operatively attached tothe interior portion of the LES of the biological passage of FIG. 1,such that there is full tissue ingrowth around portions of theartificial sphincter implant.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

I. OVERVIEW

FIGS. 1-2 show selected portions of human anatomy, which includes anesophagus (2) extending from the mouth, through a hiatus (8) defined bya diaphragm (10), and into a stomach (4). Esophagus (2) also includes adistal esophagus (3) and an LES (6). LES (6) is located along distalesophagus (3) adjacent to the junction of esophagus (2) and stomach (4).The portion of LES (6) extending through hiatus (8) is supported bydiaphragm (10). When functioning properly, LES (6) is configured totransition between an occluded state and an opened state (as shown inFIG. 2). As best seen in FIG. 2, LES (6) includes a plurality of slingfibers (12). Sling fibers (12) are smooth muscle tissue that may helpregulate LES (6) transition between the occluded state and the openstate. Hiatus (8) of diaphragm (10) may also help LES (6) transitionbetween the occluded state and the open state.

A healthy LES (6) transitions between the occluded state and the openedstate in order to act as a valve. In other words, a healthy LES (6) maytransition from the occluded state to the opened state in order to allowsolids, liquids, and/or gasses to selectively travel between esophagus(2) and stomach (4). For example, a healthy LES (6) may transition fromthe occluded state to the opened state to permit a bolus of food totravel from esophagus (2) into stomach (4) during peristalsis; or tovent intra-gastric pressure from stomach (4) toward esophagus (2).Additionally, in the occluded state, a healthy LES (6) may preventdigesting food and acidic fluid from exiting stomach (4) back intoesophagus (2).

As mentioned above, if LES (6) ceases functioning properly byprematurely relaxing, and thereby improperly transitioning esophagus (2)from the occluded state to the opened state, undesirable consequencesmay occur. Examples of such undesirable consequences may include acidicreflux from stomach (4) into esophagus (2), esophageal damage, inflamedor ulcerated mucosa, hiatal hernias, other GERD symptoms, or otherundesirable consequences as will be apparent to one having ordinaryskill in the art in view of the teachings herein. Therefore, if anindividual has an LES (6) that prematurely relaxes, causing impropertransitions from the occluded state to the opened state, it may bedesirable to insert an implant within or around a malfunctioning LES (6)such that the implant and/or LES (6) may properly transition between theoccluded state and the opened state. Several merely illustrativeexamples of such implants will be described in greater detail below.While in the current illustrative examples, implants are used toreplace/reinforce LES (6) of esophagus (2), implants may be used toreplace/reinforce any hollow organ sphincter within the body.Nonlimiting examples include the pyloric sphincter, the ileocecalsphincter, the sphincter of Oddi (or Glisson's sphincter), the sphincterurethrae (or urethral sphincter), the internal anal sphincter andexternal anal sphincter, or the upper esophageal sphincter.

II. EXEMPLARY INTERNAL ARTIFICIAL SPHINCTER IMPLANT WITH MAGNETICINTERNAL SEALS

FIG. 3 shows an exemplary implant (100) that may be attached to theinterior of a malfunctioning LES (6) to assist or effectively replaceLES (6), thereby allowing esophagus (2) to properly transition betweenthe occluded state and the opened state. In other words, implant (100)may act as an artificial sphincter. While in the current example,implant (100) is used as an artificial sphincter to assist amalfunctioning LES (6), implant (100) may be dimensioned for use as anartificial sphincter within any suitable lumen or passageway for anysuitable purpose that would be apparent to one having ordinary skill inthe art in view of the teachings herein, even in locations wherenaturally occurring sphincters are not present.

Implant (100) includes an annular retaining assembly (110) and a valveassembly (150). As will be described in greater detail below, annularretaining assembly (110) is configured to help attach implant (100)within the interior of esophagus (2) such that implant (100) does notsubstantially move longitudinally relative to esophagus (2) whileimplanted. As will also be described in greater detail below, valveassembly (150) is configured to assist or effectively replace LES (6) inproperly transitioning esophagus (2) between the occluded state and theopened state, thereby helping prevent undesirable consequences of LES(6) prematurely relaxing.

A. Exemplary Annular Retaining Assembly

Annular retaining assembly (110) includes a valve coupling annular body(112), an upper annular flange (114), a lower annular flange (116), aplurality of anchors (118), and coupling members (122). Valve couplingannular body (112) circumferentially extends around a central axis(102). In the current example, valve coupling annular body (112) has adiameter dimensioned for suitable insertion within esophagus (2), inaccordance with the description below. However, valve coupling annularbody (112) may have any suitable diameter as would be apparent to onehaving ordinary skill in the art in view of the teachings herein.Coupling members (122) are attached to and extend from an interiorfacing surface of valve coupling annular body (112). Coupling members(122) also couple with magnetic sectors (152) of valve assembly (150).In other words, coupling members (122) connect magnetic sectors (152) ofvalve assembly (150) with valve coupling annular body (112) of annularretaining assembly (110).

While in the current example central axis (102) follows a substantiallystraight line, central axis (102) may follow an approximately centralpath through a bodily lumen in which implant (100) is being insertedinto. Therefore, central axis (102), as well as valve coupling body(112) and annular flanges (114, 116), may not necessarily extend along asubstantially straight line, but may extend along a curved profile. Aplane perpendicular to, or nearly perpendicular to, central axis (102)may be referred to as an axial plane.

Upper annular flange (114) and lower annular flange (116) extend aboveand below valve coupling annular body (112), respectively, in a deployedposition. As seen in FIG. 8C, a portion of annular flanges (114, 116)directly adjacent to valve coupling annular body (112) may be consideredan “outer radial ring;” while a portion of valve coupling annular body(112) radially interior to annular flanges (114, 116) and coupling withmagnetic sectors (152) may be considered an “inner radial ring.” Upperannular flange (114) and lower annular flange (116) define notches (120)in this example. Notches (120) may promote flexibility of upper annularflange (114) and lower annular flange (116). Additionally, notches (120)may permit the folding of valve coupling annular body (112) and flanges(114, 116) radially toward central axis (102) during initial insertionof implant (100), as will be described in greater detail below.

Annular flanges (114, 116) and valve coupling annular body (112) may beflexible, elastic, and/or moldable in nature such that annular flanges(114, 116) and valve coupling annular body (112) may flex in response toexpansion, contraction, or other movement of esophagus (2); such as whenesophagus (2) performs peristalsis to move a bolus of food throughesophagus (2) toward stomach (4). As esophagus deforms during thewave-like muscle contractions of peristalsis, annular flanges (114, 116)and valve coupling annular body (112) may also deform such that theexterior portions of annular flanges (114, 116) and valve couplingannular body (112) remain in contact with, or substantially fixedrelative to, adjacent portions of the interior esophagus (2). Anchors(118) may, at least initially, help promote contact/fixed spatialpositioning between the interior esophagus (2) with annular flanges(114, 116) and valve coupling annular body (112).

Valve coupling annular body (112), upper annular flange (114), lowerannular flange (116), or any suitable combination thereof may include amaterial that is inert such that the inert material is biocompatible andresistant to reaction with biochemical solids, liquids, and gasses.Additionally, or alternatively, valve coupling annular body (112), upperannular flange (114), lower annular flange (116), or any suitablecombination/portions thereof may include a material that isbiocompatible and configured to promote tissue ingrowth. Valve couplingannular body (112), upper annular flange (114), lower annular flange(116), or any suitable combination/portions thereof may include amaterial that is biocompatible and configured to deteriorate in responseto being exposed to biochemical solids, liquids, and/or gasses(otherwise known as absorbable material). Valve coupling annular body(112), upper annular flange (114), lower annular flange (116), or anysuitable combination/portions thereof may include an absorbable materialalso configured to promote tissue ingrowth. Various suitable materialsand combinations of materials that may be used will be apparent to onehaving ordinary skill in the art in view of the teachings herein.

Anchors (118) extend radially away from an exterior surface of bothupper annular flange (114) and lower annular flange (116). Therefore,one or more anchors (118) may be presented in or near an axial plane ofimplant (100). Anchors (118) are configured to at least initially attachimplant (100) with an interior portion of esophagus (2). Therefore,anchors (118) are configured to penetrate portions of esophagus (2) toattach implant (100) within the interior of esophagus (2). Anchors(118), valve coupling annular body (112), and/or annular flanges (114,116) may be coated with a short-term adhesive to promote attaching ofimplant (100) to esophagus (2), such as cyanoacrylate, fibrin glue,oxidized regenerated cellulose, or any other suitable coating that wouldbe apparent to one having ordinary skill in the art in view of theteachings herein.

As mentioned above, anchors (118) may help promote contact, or otherwisepromote a fixed special positioning, between the interior esophagus (2)with annular flanges (114, 116) and valve coupling annular body (112).Additionally, anchors (118) may help valve coupling annular body (112)and flanges (114, 116) remain stationary (or near stationary) in thelongitudinal direction defined by central axis (102) of implant (100) asimplant (100) experiences external forces. Anchors (118) may also reducestress on portions of esophagus (2) adjacent to anchors (118). Forinstance, anchors (118) may help promote stability of valve couplingannular body (112) and flanges (114, 116) in the longitudinal directiondefined by central axis (102) when valve coupling annular body (112) andannular flanges (114, 116) are deformed during peristaltic contractionsof esophagus (2). In examples where implant (100) is used in biologicalpathways other than LES (6), anchors (118) may promote stability andreduce stress on biological pathways during circulatory pumping,excretory processes, reproductive processes, or any other suitablephysiological process that would be apparent to a person having ordinaryskill in the art in view of the teachings herein. Anchors (118) may helpreduce the amount of stress experienced by esophagus (2), or any othersuitable biological pathway, during deployment of implant (100) as willbe described in greater detail below.

Anchors (118) may include an elastic material, a metal, an alloy, apolymer, an inert material, an absorbable material, an absorbablematerial that promotes tissue growth, any other suitable material thatwould be apparent to one having ordinary skill in the art in view of theteachings herein, and/or any other suitable combination of the materialsmentioned above. Anchors (118) may be made of a material that is lesselastic than flanges (114, 116). Anchors (118) may be insert molded intoa portion of flanges (112, 114). Additionally, anchors may be wholly orpartially embedded in flanges (112, 114).

While anchors (118) are shaped like a barb or quill in the presentexample, anchors (118) may have any suitable shape that would beapparent to one having ordinary skill in the art in view of theteachings herein. For example, anchors (118) may include a staple, suchas a staple that is C-shaped or U-shaped. Anchors (118) may include acatch feature used to resist the withdrawal of anchors (118) from tissueof esophagus (2) such that anchors (118) may be used to pinch, pin, orhook into tissue. In the current example, multiple anchors (118) areused, but it should be understood that a single anchor (118) may beused. In the current example, anchors (118) extend radially away fromannular flanges (114, 116). However, anchors (118) may additionally oralternatively extend from valve coupling annular flange (112). As willbe described in greater detail below, upper and lower annular flanges(114, 116) may transition from a folded position to a substantiallyvertical position (as shown in FIG. 3) in order to deploy anchors (118)into surrounding adjacent portions of esophagus (2).

Valve coupling annular body (112), upper annular flange (114), lowerannular flange (116), anchors (118), or any suitablecombinations/portions therefore may include a coating or therapeuticsubstance. A coating may include an inert material. The therapeuticsubstances may include an agent configured to heal tissue from adisease, defect, infection, inflammation, trauma, or any combinationthereof. The therapeutic substances may include an agent configured tophysically protect tissue from acidic compounds, such as agents that actto neutralize an acidic compound. The therapeutic substances may includea drug, a steroid, an antibiotic, or any other suitable substance thatwould be apparent to one having ordinary skill in the art in view of theteachings herein. Additionally, therapeutic substances may be embeddedin a hollow area, such as a porous portion, of valve coupling annularbody (112), upper annular flange (114), lower annular flange (116), oranchors (118). Therapeutic substances may be configured to elute from aportion of the artificial sphincter into the tissue of the biologicalpassageway.

Annular body (112) and flanges (114, 116) may include portions havingdifferent flexibilities relative to each other. For instance, someportions may have a low flexibility while other portions have a highflexibility. Low flexibility portions may be thick, short, inelastic,fixed against rotation, shorter, or otherwise noncompliant. Highflexibility portions may be thin, lone, elastic, extensible, rotatable,or otherwise compliant. Anchors may be coupled to low and highflexibility portions. Anchors coupled to low flexibility portions may besubject to less stress, less displacement, or both as compared to highflexibility portions. When annular body (112) and flanges (114, 116)expand and contract in response to deformation of esophagus (2), theexpansion and contraction may be concentrated in high flexibilityportions.

B. Exemplary Valve Assembly

As best seen in FIG. 3, valve assembly (150) includes a plurality ofmagnetic sectors (152) arranged in a radially extending array aroundcentral axis (102). At least a portion of magnetic sectors (152) arepositioned within coupling members (122) or an interior of annularretaining assembly (110). Magnetic sectors (152) also define anoccludable opening (160) located near central axis (102). The term“occludable opening” is intended to include an opening that may vary insize to selectively permit or inhibit matter from undesirably passingthrough the opening.

Magnetic sectors (152) form an artificial valve. As will be described ingreater detail below, magnetic sectors (152) of valve assembly (150) areconfigured to assist or effectively replace LES (6) in properlytransitioning esophagus (2) between the occluded state and the openedstate, which may help prevent undesirable consequences of LES (6)prematurely relaxing. In particular, magnetic sectors (152) utilize amagnetic attraction between adjacent magnetic sectors (152) to bias eachother toward the occluded state. Once a sufficient external force ispresented, magnetic sectors (152) may bend, flex, or otherwise move awayfrom each other toward the opened state. When in the occluded state,magnetic sectors (152) may inhibit solids, liquids, or gasses frompassing undesirably through the interior of implant (100) (e.g., fromthe stomach (4) to the esophagus (2)). When in the opened state,magnetic sectors (152) may permit solids, liquids, or gasses to passthrough the interior of implant (100). Occludable opening (160) may bedimensioned depending on the size of substance passing throughoccludable opening.

In the present example, each magnetic sector (152) includes a flexiblebiocompatible magnetic polymer. The flexible magnetic polymer mayinclude a high-coercivity ferromagnetic compound, such as ferric oxide,mixed with a plastic binder, such as PEEK, polypropylene, high densitypolyethylene, polycarbonate, or any other suitable biocompatible polymerthat would be apparent to one having ordinary skill in the art in viewof the teachings herein. Magnetic sectors (152) may include expandedpolypropylene (EPP), high density polyethylene, or an elastomer (e.g.isoprene of sanoprene) in order to allow elastic deformation or elasticbending of magnetic sectors (152). Various suitable materials that maybe used to form magnetic sectors (152) will be apparent to those ofordinary skill in the art in view of the teachings herein.

To make magnetic sectors (152) biocompatible, magnetic sectors (152) mayhave a coating or encapsulation of a non-absorbable plastic such asPEEK, polypropylene, high density polyethylene, polycarbonate, or anyother non-absorbable plastic that would be apparent to one havingordinary skill in the art in view of the teachings herein.Alternatively, the magnetic sectors (152) may have a plating orencapsulation of another non-magnetic material like titanium.Alternatively, magnetic sectors (152) may be coated with a diamond-likecarbon (DLC) coating or bioglass which is a commercially availablefamily of bioactive glasses, composed of SiO2, Na2O, CaO, and P2o5 inspecific proportions.

While a high-coercivity ferromagnetic compound is used in the presentexample, any suitable magnetic elements may be used as would be apparentto one having ordinary skill in the art in view of the teachings herein.The magnetic portion of the magnetic polymer may be formed from rareearth magnets, paramagnetic materials, ferromagnets, or any othersuitable magnet apparent to one having ordinary skill in the art in viewof the teachings herein. Some examples of rare earth magnets include thefollowing: NdFeB (Neodymium Iron Boron), AlNiCo (Aluminum NickelCobalt), SmCo (Samarium Cobalt), Strontium ferrite, and barium ferrite.Paramagnetic materials provide a magnetism whereby the materials areattracted by an externally applied magnetic field. Some examples ofparamagnetic materials are as follows: [Cr(NH3)6]Br3, K3[Cr(CN)6],K3[MoCl6], K4[V(CN)6], [Mn(NH3)6]Cl2, (NH4)2[Mn(SO4)2]*6H2O, andNH4[Fe(SO4)2]*12H2O. Examples of ferromagnets include iron, nickel,cobalt, manganese, or their compounds (such as CrO2, MnAs, MnBi, EuO,NiO/Fe, Y3Fe5O12).

The magnetic poles of magnetic sectors (152) are aligned so thatmagnetic sectors (152) are magnetically attracted to adjacent magneticsectors (152). In particular, the magnetic pole alignment of adjacentmagnetic sectors (152) bias adjacent magnetic sectors (152) toward eachother such that occludable opening (160) is naturally magneticallybiased toward the occluded state (as shown in FIG. 4A). Additionally,magnetic sectors (152) may flexibly deform such that occludable opening(160) transitions from the occluded state to an open state (as shown inFIG. 4B) when a sufficient force overcomes the magnetic attractionbetween adjacent magnetic sectors (152), thereby pushing and flexingmagnetic sectors (152) away from each other.

Unlike conventional magnets that have distinct north and south poles,magnetic sectors (152) are flat flexible magnets made from compositematerials and may have a traditional through thickness north and southpoles, or an alternating north and south poles on the same surface. Ofcourse, magnetic sectors (152) may have any suitable north and southpole arrangement to magnetically attract adjacent magnetic sectors (152)as would be apparent to one having ordinary skill in the art in view ofthe teachings herein. As one mere example, north and south polearrangement may have an annular array of north and south pole patternson the same surface, a radially extending array of north and south polepatterns on the same surface, an arcuate array of north and south polepatterns on the same surface, etc.

Each magnetic sector (152) includes a circumferential perimeter portion(154), two radial perimeter portions (156), and a central tip (158). Inthe current example, there are four magnetic sectors (152). However, anysuitable number of magnetic sectors (152) may be used as would beapparent to one having ordinary skill in the art in view of theteachings herein. Circumferential perimeter portion (154) is dimensionedto complement the interior surface of valve coupling annular body (112)such that circumferential perimeter portions (154) abut or extend intothe interior surface of valve coupling annular body (112). In thecurrent example, circumferential perimeter portion (154) of eachmagnetic sector (152) is equally dimensioned, however this is merelyoptional. Circumferential perimeter portions (154) may have varyingdimensions as would be apparent to one having ordinary skill in the artin view of the teachings herein.

A portion of circumferential perimeter portions (154) may be affixed tocoupling members (122) of annular retaining assembly (110). Therefore,each magnetic sector (152) is attached to annular retaining assembly(110) such that at least a portion of each magnetic sector (152) isfixed to annular retaining assembly (110). Annular retaining assembly(110) may act as a mechanical ground for magnetic sectors (152), suchthat annular retaining assembly (110) allows flexing and bending ofmagnetic sectors (152) without substantially affecting the spatialpositioning of the rest of implant (100) within esophagus (2).

In the current example, coupling members (122) are positioned againstthe interior surface of valve coupling annular body (112). However,coupling members (122) may be positioned within valve coupling annularbody (112) such that circumferential perimeter portions (154) extendwithin valve coupling annular body (112). Alternatively, circumferentialperimeter portions (154) of magnetic sector (152) may extend within thevalve coupling annular body (112) such that coupling members (122) arenot required. Any suitable portion of each magnetic sector (152) may beaffixed to annular retaining assembly (110) as would be apparent to onehaving ordinary skill in the art in view of the teachings herein.

Radial perimeter portions (156) extend from a terminating end ofcircumferential perimeter portion (154) toward central axis (102).Radial perimeter portions (156) terminate radially inwardly towardcentral axis (102) into central tip (158). Radial perimeter portions(156) of directly adjacent magnetic sectors (152) are dimensioned toabut against each other in the occluded state to help form a seal.Additionally, central tips (158) are also dimensioned to abut againsteach other in the occluded state to also help form a seal. Whenpresented with a sufficient force, radial perimeter portions (156) ofdirectly adjacent magnetic sectors (152) are configured to space awayfrom each other while magnetic sectors (152) flex/bend/deform into theopened state to allow matter to pass through. Additionally, whenpresented with a sufficient force, central tips (158) are alsodimensioned to space away from each other in the opened state to allowmatter to pass through.

As best seen in FIG. 3, magnetic sectors (152) of the present exampleextend toward central axis in a flexed position such that central tips(158) extend downwardly toward stomach (4) as compared tocircumferential perimeter portion (154). This flexed position ofmagnetic sectors (152), while in the occluded state, may allow matter totravel in one direction through valve assembly (150) (i.e., fromesophagus (2) to stomach (4)) more easily as compared to a second,opposite, direction (i.e., from stomach (4) to esophagus (2)). This maybe, at least in part, caused by the geometry of how central tips (158)interact with other central tips (158). Central tips (158) do notinterfere with each other when central tips (158) flex downwardly, asindicative of matter traveling from esophagus (2) toward stomach (4).However, central tips (158) do interfere with each other when centraltips (158) flex upwardly, as indicative of matter traveling from stomach(4) toward esophagus (2). This interference may require a larger forceto expand occludable opening (160) from the occluded state to the openedstate for matter traveling from stomach (4) toward the esophagus (2) ascompared to matter traveling from esophagus (2) toward stomach (4).

C. Exemplary Performance of Internal Artificial Sphincter Implant

FIGS. 4A-4C show an exemplary functioning performance of implant (100)while properly inserted within an interior of esophagus (2), in theregion of LES (6). In particular, FIGS. 4A-4C shows valve assembly (150)transitioning from the occluded state, to the opened state, and back tothe occluded state. FIG. 4A shows implant (100) properly inserted andimplanted into esophagus (2) at the LES (6) region. Annular retainingassembly (110) may remain substantially spatially fixed relative toesophagus (2) along the longitudinal dimension. As described above, themagnetic pole alignment of adjacent magnetic sectors (152) biasesmagnetic sectors (152) toward each other such that occludable opening(160) is naturally in the occluded state. Therefore, magnetic sectors(152) are in the occluded state such that magnetic sectors (152) mayprevent the transfer of solids, fluids, and gasses from exiting stomach(4) and entering esophagus (2). In particular, radial perimeter portions(156) of directly adjacent magnetic sectors (152) may be attracted toeach other to promote sufficient contact to provide a sealing effect,while central tips (158) may also be attracted to each other to promotesufficient contact to provide a sealing effect.

As mentioned above, magnetic sectors (152) may flexibly deform such thatoccludable opening (160) transitions from the occluded state to anopened state when a sufficient force overcomes the magnetic attractionbetween adjacent magnetic sectors (152), therebypushing/flexing/deforming magnetic sectors (152) away from each other.FIG. 4B shows esophagus (2) performing a peristalsis procedure whereesophagus (2) is pushing a bolus of food (104) toward stomach (4). Thebolus of food (104) provides a sufficient force to overcome the magneticbiasing forces and to transition occludable opening (160) into theopened state such that the bolus of food (104) may pass from esophagus(2), through implant (100), and into stomach (4). Therefore, radialperimeter portions (156) and central tips (158) space away from eachother to allow bolus of food (104) to pass from esophagus (2) intostomach (4).

Once a sufficient force is no longer present (i.e., after bolus of food(104) passes through implant (100)), the magnetic attraction betweenadjacent magnetic sectors (152) will bias and flex magnetic sectors(152) back into the position associated with where occludable opening(160) in the occluded state. As shown in FIG. 4C, once bolus of food(104) passes from esophagus (2) into stomach (4), radial perimeterportion (156) and central tips (158) return to their natural positiondue to the magnetic attraction between adjacent magnetic sectors (152)to help form a seal, thereby transitioning occludable opening (160) fromthe opened state back to the occluded state.

It should be understood that magnetic sectors (152) may flex upwardlysuch that occludable opening (160) transitions from the occluded stateto the opened state. For instance, a suitable force may be provided byintra-gastric pressure from stomach (4), such that the intra-gastricpressure may be vented through implant (100) and esophagus (2) (e.g., toallow a belch). While magnetic sectors (152) may permit such desirableventing of gas from stomach (4) through esophagus (2), magnetic sectors(152) may still prevent undesirable communication of liquids and/orsolids (e.g., acid, chyme, etc.) from stomach (4) into esophagus (2).

III. EXEMPLARY DEPLOYMENT ASSEMBLY FOR INTERNAL ARTIFICIAL SPHINCTERIMPLANT

FIGS. 5-8B show a deployment assembly (170) that may be used to insertand deploy implant (100) within esophagus (2). As shown between FIGS.6A-6C, and as will be described in greater detail below, deploymentassembly (170) is configured to insert implant (100) through thepatient's mouth and within esophagus (2) in a first pre-deployedposition (FIG. 6A) in order to properly position implant (100) along theprofile of esophagus (2), to radially expand implant (100) to a secondpre-deployed position (FIG. 6B) in order to initially contact theinterior wall of esophagus (2), and transition implant (100) to adeployed position (FIG. 6C) in order to engage anchors (118) withesophagus (2), thereby substantially fixing annular retaining assembly(110) within esophagus (2).

Deployment assembly (170) includes a flexible endoscope (172)terminating at a distal end (174). Flexible endoscope (172) isdimensioned and sufficiently flexible to be inserted through the mouthof a patient and within esophagus (2). Flexible endoscope (172) alsodefines a working channel (176) that extends through distal end (174).Working channel (176) is dimensioned to slidably house a sheath (182)which surrounds a shaft (180). As will be described in greater detailbelow, the sheath (182) may slide relative to flexible endoscope (172)to radially expand implant (100) from the first pre-deployed position(FIG. 6A) to the second pre-deployed position (FIG. 6B).

The distal end of sheath (182) is coupled to a plurality of biased pivotmembers (184). Biased pivot members (184) are each coupled to arespective rotatable arm (186) extending distally from sheath (182).Therefore, biased pivot members (184) couple rotatable arms (186) tosheath (182). Rotatable arms (186) are configured to pivot relative tosheath (182) about biased pivot members (184). Each rotatable arm (186)also includes a distal end (188). Distal ends (188) of rotatable arms(186) are selectively coupled with implant (100) such that movement ofdistal ends (188) cause movement of implant (100). In particular, eachdistal end (188) is housed within a respective pocket (130) temporarilydefined by flanges (114, 116) and valve coupling annular body (112)while implant (100) is in the first and second pre-deployed positions.Distal ends (188) of rotatable arms (186) are selectively coupled withimplant (100) via an interference fit within corresponding pockets(130). Of course, distal ends (188) of rotatable arms (186) may beselectively coupled with implant (100) via any suitable means that wouldbe apparent to one having ordinary skill in the art in view of theteachings herein. Any suitable number of rotatable arms (186) may beincorporated into deployment assembly (170) as would be apparent to onehaving ordinary skill in the art in view of the teachings herein.

As mentioned above, rotatable arms (186) are configured to pivot aboutbiased pivot members (184) relative to sheath (182). As also mentionedabove, sheath (182) may slide relative to flexible endoscope (172) toradially expand implant (100). In particular, biased pivot members (184)may bias rotatable arms (186) to an outwardly extending position (asshown in FIG. 6B). However, sheath (182) may be initially located withinworking channel (176) such that rotatable arms (186) are also at leastpartially housed within working channel (176). Therefore, while biasedpivot member (184) may attempt to urge rotatable arms (186) to theoutwardly extending position, working channel (176) may constrainrotatable arms (186) to an inwardly extending position (as shown in FIG.6A). In other words, while biased pivot member (184) may naturally urgerotatable arms (186) to an outwardly extending position, working channel(176) may force rotatable arms (186) into the inwardly extendingposition if rotatable arms (186) are partially located within workingchannel (176). Because rotatable arms (186) are temporarily coupled witha flexible, elastic, and/or moldable implant (100) during the first andsecond pre-deployed positions, the location of rotatable arms (186)relative to sheath (182) (i.e. the inwardly extending position of theoutwardly extending position) may determine whether implant (100) isradially contracted in the first pre-deployed position or radiallyexpanded in the second pre-deployed position.

If sheath (182) is in a location such that a portion of rotatable arms(186) is housed within working channel (176), rotatable arms (186) maybe in the inwardly extending position, forcing implant (100) in thefirst pre-deployed position. Alternatively, if sheath is translateddistally to a location such that rotatable arms (186) are not housedwithin working channel (176), biased pivot members (184) may pivotrotatable arms (186) to the outwardly extending position, forcingimplant (100) in the second pre-deployed position. Therefore, sheath(182) may slide relative to flexible endoscope (172) in order toradially expand implant (100) within esophagus (2) from the firstpre-deployed position to the second pre-deployed position. Any suitablenumber of rotatable arms (186) may be used as would be apparent to onehaving ordinary skill in the art in view of the teachings herein.

Shaft (180) extends distally through working channel (176) and distalend (174) along central axis (102) within implant (100) such thatcentral tips (158) rest against shaft (180) when implant (100) isattached to deployment assembly (170). A plurality of inflation lines(192) extend along an exterior of shaft (180). The proximal ends (notshown) of inflation lines (192) may be in fluid communication with anysuitable fluid source, such as a syringe, pump, etc. Each inflation line(192) is also in fluid communication with an inflatable member (190). Aswill be described in greater detail below inflation lines (192) maycommunicate fluid from fluid source (not shown) into inflatable member(190) to expand inflatable member (190). Inflatable members (190) arehoused with pockets (130) temporarily defined by flanges (114, 116)folded radially inwardly toward valve coupling annular body (112). Asmentioned above, pocket (130) is defined while implant (100) is in thefirst and second pre-deployed positions.

When flanges (114, 116) are folded radially inwardly to define pockets(130), anchors (118) are in a disengaged position. When in thedisengaged position, anchors (118) are angled to help prevent accidentalcontact between anchors (118) and the interior of esophagus (2).Therefore, it may be easier to insert implant (100) within esophagus (2)with anchors (118) in the disengaged position such that anchors (118) donot accidentally snag a portion of esophagus (2) during insertion ofimplant (100). Conversely, anchors (118) may be presented to penetrate,or otherwise couple with, esophagus (2) in an engaged position. As willbe described in greater detail below, inflatable members (190) areconfigured to selectively expand in order to drive implant (100) fromthe second pre-deployed position into the deployed position such thatflanges (114, 116) fold radially outwardly, causing anchors (118) totransition from the disengaged position to the engaged position. Anchors(118) may penetrate, or otherwise couple with, esophagus (2) in theengaged position.

Alternatively, a sheath may cover annular body (112) and flanges (114,116) to keep anchors (118) in the disengaged position. The sheath mayprevent anchors (118) from extending radially away from flanges (114,116). The sheath may then be removed to encourage anchors (118) totransition to the engaged position.

FIGS. 6A-8C show an exemplary deployment of implant (100) wheredeployment assembly (170) is used to insert and deploy implant (100)within esophagus (2). First, as best seen in FIG. 6A, biased pivotmembers (184) are within working channel (176) such that portions ofrotatable arms (186) are also located within working channel (176). Asmentioned above, flanges (114, 116) are folded radially inwardly todefine pockets (130), with which distal ends (188) of rotatable arms(186) are coupled. Therefore, working channel (176) constrains rotatablearms (186) in the inwardly extending position as described above suchthat implant (100) is in the first pre-deployed position. Becauseannular retaining assembly (110) of implant (100) is coupled todeployment assembly (170) and folded radially inwardly in the firstpre-deployed position, an operator may insert deployment assembly (170)and implant (100) through the mouth and within esophagus (2) untilimplant (100) is located adjacent to the desired implant location withinesophagus (2) (e.g., in the region of LES (6)).

As best seen in FIGS. 6B and 7A, the operator may then slide sheath(182) distally through working channel (176) such that rotatable arms(186) are no longer partially constrained within working channel (176).Because working channel (176) is no longer constraining rotatable arms(186), biased pivot members (184) urge rotatable arms (186) to pivotabout biased pivot members (184) from the inwardly extending position tothe outwardly extending position. Because distal ends (188) of rotatablearms (186) are still coupled within implant (100) via pockets (130), andbecause annular flanges (114, 116) and valve coupling annular body (112)are flexible, elastic, moldable, and/or malleable, pivoting of rotatablearms (186) radially expands annular retaining assembly (110) from thefirst pre-deployed position to the second pre-deployed position.Therefore, valve coupling annular body (112) abuts against the interiorwall of esophagus (2). At this point, flanges (114, 116) are stillfolded radially inwardly relative to valve coupling annular body (112),thereby maintaining anchors (118) in the disengaged position.

With implant (100) placed in the desired location of esophagus (2)(e.g., within the region of LES (6)), the operator may thensubstantially fix annular retaining assembly (110) within esophagus (2)by transitioning implant (100) from the second pre-deployed position tothe deployed position. To that end, as best seen between FIGS. 6B-6C and8A-8C, the operator may drive fluid from a fluid source (not shown),through inflation lines (192) and into inflatable members (190) suchthat inflatable members (190) expand from a deflated configuration (asshown in FIGS. 6B and 8A) into a partially inflated configuration (asshown in FIG. 8B), and finally into a completely inflated configuration(as shown in FIGS. 6C and 8C).

As best seen between FIGS. 8A-8C, because inflatable members (190) arehoused within pockets (130), inflation of inflatable members (190)drives flanges (114, 116) vertically away from valve coupling annularbody (112) and toward the interior lining of esophagus (2). Becauseanchors (118) are attached to flanges (114, 116), anchors (118) arefolded radially outwardly, thereby penetrating esophagus (2), andpossibly mascularis (14), to secure annular retaining assembly (110)within esophagus (2). In other words, inflation of inflatable members(190) may drive anchors (118) to penetrate an interior surface ofesophagus (2). Because inflation of inflatable members (190) drivesflanges (114, 116) away from valve coupling annular body (112),temporary pockets (130) are no longer defined when implant (100)transitions into the deployed position (as shown in FIGS. 6C and 8C).Therefore, inflatable members (190) and distal ends (188) of rotatablearms (186) are no longer coupled with implant (100). As best seen inFIG. 7, once inflatable members (190) drive implant (100) into thedeployed position, deployment assembly (170) may be removed fromesophagus (2) while leaving annular retaining assembly (110)substantially fixed within the interior of esophagus (2).

While implant (100) and deployment assembly (170) of the present exampleare configured to first radially expand annular retaining assembly (110)and then deploy anchors (118) to engage esophagus (2) in separatestages, this is merely optional. For instance, anchors (118) may beangled on flanges (114, 116) such that anchors (118) may partiallyengage interior of esophagus (2) when implant (100) is expanded into thesecond pre-deployed position. Additionally, while anchors (118) aremeant to be deployed by being driven radially outwardly in the presentexample, anchors (118) may also be twisted or rotated about axis (102)to engage esophagus (2).

Alternatively, anchors (118) may be configured to attach to esophagus(2) substantially simultaneously while annular body (112) expands fromthe first pre-deployed position to the second pre-deployed position. Forinstance, valve coupling annular body (112) may include a moldable ormalleable material such that when annular body (112) expands away fromcentral axis (102) while being deployed (similar to the transitionbetween the first and second pre-deployed position), annular body (112)becomes thinner in the radial direction. Anchors (118) may be entirelyhoused within annular body (112) before annular body (112) expands inthe radial direction. Further, anchors (118) may be attached to aninterior portion of annular body (112) such that as annular body (112)expands in the radial direction, anchors (118) start to extend from anexterior surface of annular body (112) in an outward radial direction toengage esophagus (2). Therefore, anchors (118) may be automaticallyexposed while annular body (112) is expanded. This feature may permitinsertion of annular body (112) into a passageway while annular body(112) is in the retracted position and anchor (118) are entirelysheathed. If anchors (18) are in the form of a catch, this feature maypermit anchors (118) to pin a portion of the interior of biologicalpassage against annular body (112) when annular body (112) contracts.

As mentioned above, annular retaining assembly (110) may includematerial that is configured to promote tissue growth after insertion.Additionally, such material may also be absorbable, such that at least aportion of annular retaining assembly (110) breaks down while tissuegrowth replaces the material to ensure structure integrity of annularretaining assembly (110). FIGS. 9A-9C show an implanted annularretaining assembly (110) including an absorbable material that isconfigured to promote tissue growth over various periods of time withinesophagus (2). Additionally, annular retaining assembly (110) alsoincludes a plurality of inert non-absorbable structures (124) extendingwithin the absorbable material defining valve coupling annular body(112) and flanges (114, 116).

FIG. 9A shows annular retaining assembly (110) just after implantation.At this point, annular retaining assembly (110) is substantiallylongitudinally fixed relative to esophagus (2) based on the holdingstrength of anchors (118). Additionally, absorbable material defininganchors (118), valve coupling annular body (112), and flanges (114, 116)are still structurally intact such that absorbable material has yet tobreak down and tissue in-growth has yet to occur.

After a suitable amount of time after implantation, as shown in FIG. 9B,absorbable material defining valve coupling annular body (112) andflanges (114, 116) starts to break down while tissue in-growth (126)starts to take the place of absorbable material. Inert non-absorbablestructures (124) remain intact as they do not break down or promotetissue in-growth (126). Anchors (118) may or may not have begun to breakdown, but still at least partially help substantially secure annularretaining assembly (110) to esophagus (2). It should be understood atthis point, that magnetic sectors (152) are still operable to flex anddeform relative to esophagus (2) while portions of magnetic sectors(152) remain substantially spatially fixed relative to esophagus (2).

FIG. 9C show implant (100) after absorbable material defining annularbody (120), flanges (114, 116), and anchors (118) has broken down andbeen structurally replaced by tissue in-growth (126). Therefore, anchors(118) may no longer help spatially fix annular retaining assembly (110)relative to esophagus (2). Non-absorbable structures (124) still remainintact. Magnetic sectors (152) are still operable to flex and deformrelative to esophagus (2) while portions of magnetic sectors (152)remain substantially spatially fixed relative to esophagus (2). Whiletissue in-growth (126) has replaced absorbable material, implant (100)is sufficiently attached to esophagus (2) to remain substantiallyspatially fixed during operation. However, tissue in-growth (126) hasbeen suitably retarded due to non-absorbable structures (124). While acertain degree of tissue in-growth (126) has been accomplished, it issuitably limited in case an operator wishes to eventually remove implant(100). Therefore, an operator may apply enough force to implant (100),and/or incise tissue in-growth (126), to remove implant from esophagus(2) without damaging esophagus (2), if desired.

IV. EXEMPLARY INTERNAL ARTIFICIAL SPHINCTER IMPLANT WITH OVERLAPPINGMAGNETIC Internal Seals

FIGS. 10-12B show an exemplary alternative implant (200) that may beused in place of implant (100) described above. Implant (200) includesan annular retaining assembly (210) and a valve assembly (250). Annularretaining assembly (210) extends circumferentially around a central axis(202), which may be substantially similar to central axis (102)described above. Annular retaining assembly (210) is substantiallysimilar to annular retaining assembly (110) described above. Therefore,annular retaining assembly (210) includes a valve coupling annular body(212), an upper annular flange (214), a lower annular flange (216), aplurality of anchors (218), and notches (220); which are substantiallysimilar to valve coupling annular body (112), upper annular flange(114), lower annular flange (116), anchors (118), and notches (120)described above, respectively.

Similar to valve assembly (150) described above, valve assembly (250)includes a plurality of flexible magnetic sectors (252) defining anoccludable opening (260) that may transition between an occluded state(FIGS. 10 and 12A) and an opened state (FIG. 12B). Therefore, magneticsectors (252) utilize a magnetic attraction with adjacent magneticsectors (252) to bias against each other toward the occluded state. Oncea sufficient external force is presented, magnetic sectors (252) maymove/flex/bend away from each other toward the opened state. When in theoccluded state, magnetic sectors (252) may inhibit solids, liquids, orgasses from passing undesirably through the interior of implant (200)(e.g., from the stomach (4) toward the esophagus (2)). When in theopened state, magnetic sectors (252) may permit solids, liquids, orgasses to pass through the interior of implant (200). Occludable opening(260) may be dimensioned depending on the size of substance passingthrough occludable opening (260).

Flexible magnetic sectors (252) may be made out the same materials andhave similar magnetic pole patterns as magnetic sectors (150) describedabove. However, flexible magnetic sectors (252) have a differentgeometry as compared to magnetic sectors (150) described above. Insteadof having magnetic sectors (152) with radial perimeter portions (156)directly adjacent to each other with little to no overlap, flexiblemagnetic sectors (252) overlap with each other such that portions offlexible magnetic sectors (252) are stacked on top of each other toprovide a sealing effect.

Each magnetic sector (252) includes a circumferential perimeter portion(254), a top radial perimeter portion (256), a bottom radial perimeterportion (258), and a central arcuate portion (258). Like circumferentialperimeter portion (154) described above, circumferential perimeterportion (254) is attached to valve coupling annular body (212) in orderto couple each magnetic sector (252) with annular retaining assembly(210). Top radial perimeter portions (256) and bottom radial perimeterportions (258) extend radially toward central axis (202) and terminateinto respective arcuate portions (257). Top radial perimeter portion(256) rests on top of adjacent magnetic sectors (252) while bottomradial perimeter portion (258) rests below adjacent magnetic sectors(252) to define an overlapping formation. However, any suitable patternof layered radial portions may be used as would be apparent to onehaving ordinary skill in the art in view of the teachings herein. Forinstance, one magnetic sector (252) may have two radial perimeterportions resting the on the bottom or the top of adjacent magneticsectors (252).

In the current example, there are four magnetic sectors (252) in auniform radially extending array that is angularly offset by 90 degrees.However, any suitable number of magnetic sectors (252) may be used andany suitable offset angle(s) may be used as would be apparent to onehaving ordinary skill in the art in view of the teachings herein. Whilethe radially extending array of magnetic sectors (252) is uniformlyoffset in the current example, this is merely optional. Additionally, inthe current example, circumferential perimeter portion (254) extendscircumferentially around central axis (202) approximately 225 degrees.However, circumferential perimeter portion (254) may circumferentiallyextend around central axis (202) to define any suitable angle as wouldbe apparent to one having ordinary skill in the art in view of theteachings herein.

The magnetic poles of magnetic sectors (252) are aligned so thatmagnetic sectors (252) are magnetically attracted to overlappingportions of adjacent magnetic sectors (252). In particular, the magneticpole alignment of overlapping portions of magnetic sectors (252) biastoward and against each other such that occludable opening (260) ismagnetically biased toward an occluded state (as shown in FIGS. 10 and12A). Overlapping portions of adjacent magnetic sectors (252) form aseal that inhibits solids, liquids, and gasses from undesirably passingthrough implant (200). Additionally, magnetic sectors (252) may flexiblydeform such that occludable opening (260) transitions from the occludedstate to an open state (as shown in FIG. 12B) when a sufficient forceovercomes the magnetic attraction between overlapping magnetic sectors(252), thereby pushing and flexing overlapping portions of magneticsectors (252) away from each other. In the opened state, occludableopening may allow solids, liquids, and gasses to pass through implant(200).

FIGS. 12A-12B show an exemplary use of implant (200) once properlydeployed in esophagus (2), where annular retaining assembly (210)remains substantially spatially fixed relative to esophagus (2). Itshould be understood that implant (200) may be deployed in asubstantially similar fashion as implant (100) described above.Therefore, implant (200) is compatible with deployment assembly (170)described above. FIG. 12A shows implant (200) in the occluded state. Asdescribed above, the magnetic pole alignment of overlapping portions ofmagnetic sectors (252) biases magnetic sectors (252) toward and againsteach other such that occludable opening (260) is naturally in theoccluded state. Therefore, magnetic sectors (252) may prevent solids,fluids, and gasses from exiting stomach (4) and entering esophagus (2).In particular, overlapping portions of directly adjacent magneticsectors (152) may be attracted to each other to promote sufficientcontact to provide a sealing effect.

As mentioned above, magnetic sectors (252) may flexibly deform such thatoccludable opening (260) transitions from the occluded state to anopened state when a sufficient force overcomes the magnetic attractionbetween adjacent magnetic sectors (252), therebypushing/flexing/deforming overlapping portions of magnetic sectors (252)away from each other. In the current example, FIG. 12B shows esophagus(2) performing a peristalsis procedure where esophagus (2) is pushing abolus of food (104) toward stomach (4). The bolus of food (104) providesa sufficient force to overcome the magnetic biasing forces andtransition occludable opening (260) into the opened state such that thebolus of food (104) may pass from esophagus (2), through implant (200),and into stomach (4). Therefore, overlapping portions of magneticsectors (252) space away from each other to allow bolus of food (104) topass through occludable opening (260) from esophagus (2) into stomach(4).

It should be understood that once bolus of food (104) completely passesthrough occludable opening (260), a sufficient force overcoming themagnetic biasing forces of magnetic sectors (252) is no longer present.Therefore, the magnetic biasing forces of magnetic sectors (252) urgemagnetic sectors (252) back into the occluded state as shown in FIG.12A.

Magnetic sectors (252) may extend toward central axis in a downwardangle. This downwardly angled position of magnetic sectors (252), whilein the occluded state, may allow matter to travel in one directionthrough valve assembly (250) (i.e., from esophagus (2) to stomach (4))more easily as compared to a second, opposite, direction (i.e., fromstomach (4) to esophagus (2)). This may be, at least in part, caused bythe geometry of how central arcuate portions (257) interact with eachother. Central arcuate portions (257) do not interfere with each otherwhen central arcuate portions (257) flex downwardly, as indicative ofmatter traveling from esophagus toward stomach (4). However, centralarcuate portions (257) do interfere with each other when central arcuateportions (257) flex upwardly, as indicative of matter traveling fromstomach (4) toward esophagus (2). This interference may require a largerforce to expand occludable opening (260) from the occluded state to theopened state for matter traveling from stomach (4) toward the esophagus(2) as compared to matter traveling from esophagus (2) toward stomach(4).

V. EXEMPLARY INTERNAL ARTIFICIAL SPHINCTER IMPLANT WITH ALTERNATIVEMAGNETIC RESTRAINTS

FIGS. 13A-14B show another alternative implant (400) that may be used inplace of implant (100, 200) described above. Implant (400) includes anannular retaining assembly (410) and a valve assembly (450). Annularretaining assembly (410) extends circumferentially around a central axis(402), which may be substantially similar to central axis (102, 202)described above. Annular retaining assembly (410) is substantiallysimilar to annular retaining assembly (110, 210) described above.Therefore, annular retaining assembly (410) includes a valve couplingannular body (412), an upper annular flange (414), a lower annularflange (416), and a plurality of anchors (418); which are substantiallysimilar to valve coupling annular body (112, 212), upper annular flange(114, 214), lower annular flange (116, 216), and anchors (118, 218, 318)described above, respectively.

Valve assembly (450) includes an annular array of spherical magnets(452) and spacing members (456) encased in a highly flexible siliconebag (455). Highly flexible silicone bag (455) defines an occludableopening (460) that may transition from an occluded state to an openedstate. As will be described in greater detail below, spherical magnets(452) are aligned to magnetically bias highly flexible silicone bag(455) toward the occluded state (as shown in FIG. 14A). Once asufficient force is presented, highly flexible silicone bag (455) maymove/flex/bend radially away from central axis (402) such thatoccludable opening (460) transitions into the opened state (as shown inFIG. 14B). When in the occluded state, valve assembly (450) may inhibitsolids, liquids, or gasses from passing undesirably through the interiorof implant (400). When in the opened state, valve assembly (450) maypermit solids, liquids, or gasses to pass through the interior ofimplant (400). Occludable opening (460) may be dimensioned depending onthe size of substance passing through occludable opening (460).

Spacing members (456) and spherical magnets (452) are arranged in analternating annular pattern. Additionally, spacing members (456) andspherical magnets (452) are additionally coupled to each other by aflexible cord (454) extending through pathways (453) defined by bothspherical magnets (452) and spacing members (456). Cord (454) may flexto accommodate movement of spherical magnets (452) and spacing members(456) relative to each other.

As seen between FIGS. 13A-13B, spherical magnets (452) and spacingmembers (456) may move toward and away each other to deform highlyflexible silicone bag (455). Highly flexible silicone bag (455) isconnected to an interior surface of valve coupling annular body (412).Highly flexible silicone bag (455) may be attached to the interiorsurface of valve coupling annular body (412) such that as highlyflexible silicone bag (455) expands and contracts between the occludedstate and the opened state, valve coupling annular body (412) also atleast partially expands and contracts in the radial direction. However,this is merely optional. While silicone is used in highly flexiblesilicone bag (455) in the current example, any other suitable elastomermay be used as would be apparent to one having ordinary skill in the artin view of the teachings herein.

Spherical magnets (452) are aligned such that opposite poles of adjacentspherical magnets (452) are facing each other in a circumferentialpattern, thereby promoting a magnetic attraction between adjacentspherical magnets (452). Therefore, spherical magnets (452) aremagnetically attracted to each toward each other along a circumferentialdimension. Spacing members (456) each define two complementary archedsurfaces (458) facing opposite directions and dimensioned to accommodateat least a portion of adjacent spherical magnets (452) when highlyflexible silicone bag (455) is in the occluded state. Therefore, spacingmembers (456) may control the minimum distance adjacent sphericalmagnets (452) are relative to each other. Because magnetic force betweenspherical magnets (452) is at least partially determined by the distancebetween adjacent spherical magnets (452), spacing members (456) may bedimensioned to control or limit the maximum magnetic attraction forcebetween adjacent spherical magnets (452).

In the current example, seven spherical magnets (452) and seven spacingmembers (456) are used. However it should be understood that anysuitable number of magnets (452) and spacing members (456) may be usedas would be apparent to one having ordinary skill in the art in view ofthe teachings herein. In the current example, spherical magnets (452)include rare earth magnets, however, any other suitable magnet may beused as would be apparent to one having ordinary skill in the art inview of the teachings herein.

The polarity alignment of spherical magnets (452) magnetically urgehighly flexible silicone bag (455), as well as occludable opening (460),toward a sealed occluded state (as shown in FIG. 14A). Additionally,when a sufficient force overcomes the magnetic forces between magnets(452), the annular array of spherical magnets (452) and spacing members(456) space away from central axis (402) such that highly flexiblesilicone bag (455) may flexibly deform to transition occludable opening(460) from the occluded state to the opened state (as shown in FIG.14B). In the opened state, occludable opening may allow solids, liquids,and gasses to pass through implant (400).

FIGS. 14A-14B show an exemplary use of implant (400) once properlydeployed in esophagus (2). Therefore, annular retaining assembly (410)may remain substantially spatially fixed relative to esophagus (2). Itshould be understood that implant (400) may be deployed in asubstantially similar fashion as implant (100) described above.Therefore, implant (400) is compatible with deployment assembly (170)described above. FIG. 14A shows implant (400) in the occluded state. Asdescribed above, the polarity alignment of spherical magnets (452)magnetically urges second highly flexible silicone bag (455) toward asealed occluded state. Therefore, valve assembly (450) may prevent thetransfer of solids, fluids, and gasses from exiting stomach (4) andentering esophagus (2).

As mentioned above, valve assembly (450) may flexibly deform such thatoccludable opening (460) transitions from the occluded state to anopened state when a sufficient force overcomes the magnetic forcesbetween spherical magnets (452), thereby pushing/flexing/deforminghighly flexible silicone bag (455) away from central axis (402). In thecurrent example, FIG. 14B shows esophagus (2) performing a peristalsisprocedure where esophagus (2) is pushing a bolus of food (104) towardstomach (4). The bolus of food (104) provides a sufficient force toovercome the magnetic biasing forces and transition occludable opening(460) into the opened state such that the bolus of food (104) may passfrom esophagus (2), through implant (400), and into stomach (4).Therefore, the annular array of spherical magnets (452) and spacingmembers (456) space away from central axis (402) such that highlyflexible silicone bag (455) flexibly deforms occludable opening (460)into the opened state to allow bolus of food (104) to pass throughoccludable opening (460) from esophagus (2) into stomach (4).

It should be understood that once bolus of food (104) completely passesthrough occludable opening (460), a sufficient force overcoming themagnetic biasing forces of spherical magnets (452) is no longer present.Therefore, the magnetic biasing forces of magnets (452) urge the annulararray of spherical magnets (452) and spacing members (456) toward eachother, and therefore highly flexible silicone bag (455) back into theoccluded state as shown in FIG. 14A.

VI. EXEMPLARY ALTERNATIVE ARTIFICIAL IMPLANT WITH ALTERNATIVE ANNULARRETAINING ASSEMBLIES

FIG. 15 shows an exemplary alternative artificial implant (600) that maybe used in place of implant (200) described above. Therefore, artificialimplant (600) may function substantially similar to implant (200)described above, with differences elaborated below. Implant (600) may beinserted and deployed within esophagus (2) via deployment assembly (170)in accordance with the principles described above. Implant (600)includes an annular retaining assembly (610) and a valve assembly (650)defining an occludable opening (660). Valve assembly (650) issubstantially similar to valve assembly (250) described above, withdifference elaborated below. Therefore, valve assembly (650) includes aplurality of overlapping magnetic sectors (652), each including acircumferential perimeter portion (654), a top radial perimeter portion(656), a bottom radial perimeter portion (658), and a central arcuateportion (657); which are substantially similar to overlapping magneticsectors (252), each including a circumferential perimeter portion (254),a top radial perimeter portion (256), a bottom radial perimeter portion(258), and a central arcuate portion (257) described above,respectively. Therefore, magnetic sectors (652) are configured totransition from an occluded state to an opened state when properlydeployed within the interior of an esophagus (2).

Additionally, each magnetic sector (652) defines a circumferential arrayof openings (662). As will be described in greater detail below,circumferential array of openings (662) are configured to couple eachmagnetic sector (652) with an inert portion of annular retainingassembly (610).

Similar to annular retaining assembly (110) described above, annularretaining assembly (610) includes a valve coupling annular body (612),an upper annular flange (614), a lower annular flange (616), and aplurality of anchors (618) which may substantially similar to valvecoupling annular body (112), an upper annular flange (114), lowerannular flange (616), and plurality of anchors (118) described above,respectively, with differences elaborated below. As mentioned above,annular retaining assembly (110) may include a combination of materialsincluding inert materials as well as absorbable materials that promotetissue growth. As also mentioned above, it may be desirable to promote asufficient amount of tissue growth after deploying of implant (600) tohelp spatially fix implant (600) during operation, while also suitablyretarding such tissue growth such that an operator may selectivelyremove implant (600) from esophagus (2) if desired. Annular retainingassembly (610) includes a sufficient combination of inert materials andabsorbable materials promoting tissue growth to achieve both functions.

In the present example, valve coupling annular body (612) and flanges(614, 616) are defined by an outer weave (620) filled with verticalcolumn-like threads (622). Outer weave (620) may cover exterior portionsof annular body (612) and flanges (614, 616) while vertical column-likethreads (622) may fill an interior portion of outer weave (620) to fillout annular body (612) and flanges (614, 616). Therefore, outer weave(620) has an exterior surface facing away from column-like threads (622)and an interior surface that is adjacent to column-like threads (622).Outer weave (620) may be made out of an absorbable material such thatover a period of time after deployed within esophagus (2), outer wave(620) may dissolve. Vertical column-like threads (622) may be made outof a material configured to promote a suitable amount of tissue growthsuch that implant (600) may remain stationary during operation, but alsosuch that implant (600) may be removed from esophagus (2) when desiredwithout causing substantial damage. Of course, outer weave (620) andvertical column-like threads (622) may be both made out of absorbablematerial configured to promote tissue growth such that after a suitabletime deployed within esophagus (2), tissue begins to grow around and/orreplace outer weave (620) and vertical column-like threads (622). Anyother suitable combination of materials for outer weave (620) andvertical column-like threads (622) may be used as would be apparent toone having ordinary skill in the art in view of the teachings herein.Outer weave (620) and vertical column-like threads (622) may form afibrous absorbable lattice that may include both absorbable polymers andnon-absorbable polymers such as nylon and polypropylene.

The materials for valve coupling annular body (612) and flanges (614,616) can include bioabsorbable and biocompatible polymers, includinghomopolymers and copolymers. Non-limiting examples of homopolymers andcopolymers include p-dioxanone (PDO or PDS), polyglycolic acid (PGA),poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL),trimethylene carbonate (TMC), and polylactic acid (PLA), poly(glycolicacid-co-lactic acid) (PLA/PGA) (e.g., PLA/PGA materials used in Vicryl,Vicryl Rapide, PolySorb, and Biofix), polyurethanes (such as Elastane,Biospan, Tecoflex, Bionate, and Pellethane fibers), polyorthoesters,polyanhydrides (e.g., Gliadel and Biodel polymers), polyoxaesters,polyesteramides, and tyrosine-based polyesteramides. The copolymers canalso include polylactic acid-co-polycaprolactone) (PLA/PCL), poly(L-lactic acid-co-polycaprolactone) (PLLA/PCL), poly(glycolicacid-co-trimethylene carbonate) (PGA/TMC) (e.g., Maxon), Poly(glycolicacid-co-caprolactone) (PCL/PGA) (e.g., Monocryl and Capgly), PDS/PGA/TMC(e.g., Biosyn), PDS/PLA, PGA/PCL/TMC/PLA (e.g., Caprosyn), andLPLA/DLPLA (e.g., Optima). The polymers may also have medicants, suchexamples may also be further constructed and operable in accordance withat least some of the teachings of U.S. Pub. No. 2017/0055986, entitled“Medicant Eluting Adjuncts and Methods of Using Medicant ElutingAdjuncts,” published Mar. 2, 2017, the disclosure of which isincorporated by reference herein.

Circumferential perimeter portions (654) may extend into portions ofouter weave (620) and vertical column-like threads (622) such that outerweave (620) and vertical column-like threads (622) are attached tomagnetic sectors (652) before outer weave (620) and vertical column-likethreads (622) are absorbed. Outer weave (620) and vertical column-likethreads (622) may be resiliently compressible such that outer weave(620) and column-like threads (622) may deform in response to anexternal force and then return to a natural shape.

Additionally, annular retaining assembly (610) includes a coiled suture(624) that is initially housed within valve coupling annular body (612).Coiled suture (624) may be made out of an inert material. Coiled suture(624) may couple with each magnetic sector (652) via coupling means(626) or through circumferential array of opening (662). Coiled suture(624) is configured to hold together overlapping magnetic sectors (652)after valve coupling annular flanges (612) and flanges (614, 616) areabsorbed. Coiled suture (624) may sufficiently retard tissue growtharound overlapping magnetic sectors (652) such that when an operatordesires to remove implant (600) from esophagus (2), removal may limittissue damage around adjacent portions of esophagus (2). Additionally,coiled suture (624) may keep magnetic sectors (652) suitably connectedto each other. Therefore, coiled suture (624) may spatially fix magneticsectors (652) relative to each other after outer weave (620) andvertical column-like threads (622) are absorbed. Additionally, coiledsuture (624) may allow magnetic sectors (652) to be removed unitarilyfrom esophagus (2) after outer weave (620) and vertical column-likethreads (622) are absorbed.

Valve coupling annular body (612), upper annular flange (614), lowerannular flange (616), anchors (618), coiled suture (624), outer weave(620), vertical column-like threads (622), or any suitablecombinations/portions therefore may include a coating or therapeuticsubstance. A coating may include an inert material. The therapeuticsubstances may include an agent configured to heal tissue from adisease, defect, infection, inflammation, trauma, or any combinationthereof. The therapeutic substances may include an agent configured tophysically protect tissue from acidic compounds, such as agents that actto neutralize an acidic compound. The therapeutic substances may includea drug, a steroid, an antibiotic, or any other suitable substance thatwould be apparent to one having ordinary skill in the art in view of theteachings herein. Non-limiting examples of therapeutic substances mayinclude antimicrobial agents, antifungal agents, anti-inflammatoryagents, and growth factors. Non-limiting examples of antimicrobialagents include Ionic Silver, Triclosan, Tetracyclines, Doxycycline,Minocycline, Demeclocycline, Tetracycline, Oxytetracycline, Gentamicin,Neomycin, Non-limiting examples of antifungal and antimicrobial agentsinclude Triclosan, Triazole, Thiazole, LAE, Sodium Stearate,Non-limiting examples of anti-inflammatory agents include non-steroidalanti-inflammatory agents (e.g., Salicylates, Aspirin, Diflunisal,Propionic Acid Derivatives, Ibuprofen, Naproxen, Fenoprofen, andLoxoprofen), acetic acid derivatives (e.g., Tolmetin, Sulindac, andDiclofenac), enolic acid derivatives (e.g., Piroxicam, Meloxicam,Droxicam, and Lornoxicam), anthranilic acid derivatives (e.g., MefenamicAcid, Meclofenamic Acid, and Flufenamic Acid), selective COX-2inhibitors (e.g., Celecoxib (Celebrex), Parecoxib, Rofecoxib (Vioxx),Sulfonanilides, Nimesulide, and Clonixin), immune selectiveanti-inflammatory derivatives, corticosteroids (e.g., Dexamethasone),and iNOS inhibitors, Non-limiting examples of growth factors includethose that are cell signaling molecules that stimulate cell growth,healing, remodeling, proliferation, and differentiation. Exemplarygrowth factors can be short-ranged (paracrine), long ranged (endocrine),or self-stimulating (autocrine). Further examples of the growth factorsinclude growth hormones (e.g., a recombinant growth factor, Nutropin,Humatrope, Genotropin, Norditropin, Saizen, Omnitrope, and abiosynthetic growth factor), Epidermal Growth Factor (EGF) (e.g.,inhibitors, Gefitinib, Erlotinib, Afatinib, and Cetuximab),heparin-binding EGF like growth factors (e.g., Epiregulin, Betacellulin,Amphiregulin, and Epigen), Transforming Growth Factor alpha (TGF-a),Neuroregulin 1-4, Fibroblast Growth Factors (FGFs) (e.g., FGF1-2, FGF2,FGF11-14, FGF18, FGF15/19, FGF21, FGF23, FGF7 or Keratinocyte GrowthFactor (KGF), FGF10 or KGF2, and Phenytoin), Insuline-like GrowthFactors (IGFs) (e.g., IGF-1, IGF-2, and Platelet Derived Growth Factor(PDGF)), Vascular Endothelial Growth Factors (VEGFs) (e.g., inhibitors,Bevacizumab, Ranibizumab, VEGF-A, VEGF-B, VEGF-C, VEGF-D andBecaplermin). The therapeutic substances may also include othermedicants, such examples may also be further constructed and operable inaccordance with at least some of the teachings of U.S. Pub. No.2017/0055986, entitled “Medicant Eluting Adjuncts and Methods of UsingMedicant Eluting Adjuncts,” published Mar. 2, 2017, the disclosure ofwhich is incorporated by reference herein.

Additionally, therapeutic substances may be embedded in a hollow area,such as a porous portion, of valve coupling annular body (612), upperannular flange (614), lower annular flange (616), anchors (618), coiledsuture (624), outer weave (620), or vertical column-like threads (622).Therapeutic substances may be configured to elute from a portion of theartificial sphincter into the tissue of the biological passageway.

FIG. 16 shows an exemplary alternative artificial implant (700) that maybe used in place of implant (400) described above. Therefore, implant(700) may function substantially similar to implant (400) describedabove, with differences elaborated below. Implant (700) may be insertedand deployed within esophagus (2) via deployment assembly (170) inaccordance with the principles described above. Implant (700) includesan annular retaining assembly (710) and a valve assembly (750) definingan occludable opening (760). Valve assembly includes an annular array ofspherical magnets (752) and spacing members (756) coupled together by aflexible cord (754), and a highly flexible silicone bag (755) definingoccludable opening (760). Spherical magnets (752), spacing members(756), flexible cord (754) and highly flexible silicon bag (755) aresubstantially similar to spherical magnets (452), spacing members (456),flexible cord (454) and highly flexible silicone bag (455) describedabove, respectively, with differenced described below.

While spherical magnets (452) and spacing members (456) are housedwithin highly flexible silicone bag (455), spherical magnets (752) andspacing members (756) are housed within a magnetic assembly housing(732) defined by a flexible internal annular sleeve (730) located withinannular retaining assembly (710). Annular retaining assembly (710) maybe include a non-absorbable material. Additionally, highly flexiblesilicone bag (755) is also coupled to annular retaining assembly (710).Therefore, annular retaining assembly (710) acts as an intermediarybetween spherical magnets (752) and highly flexible silicone bag (755).In other words, when spherical magnets (752) and spacing members (756)move relative to each other radially, both annular retaining assembly(710) and highly flexible silicone bag (755) also move radially totransition occludable opening (760) between the occluded state and theopened state.

Similar to annular retaining assembly (410) described above, annularretaining assembly (710) includes a valve coupling annular body (712),an upper annular flange (714), a lower annular flange (716), and aplurality of anchors (718), which may substantially similar to valvecoupling annular body (412), upper annular flange (414), lower annularflange (416), and plurality of anchors (418) described above,respectively, with differences elaborated below. As mentioned above,annular retaining assembly (110) may include a combination of materialsincluding inert materials as well as absorbable materials that promotetissue growth. As also mentioned above, it may be desirable to promote asufficient amount of tissue growth after deploying of implant (700) tohelp spatially fix implant (700) during operation, while also suitablyretarding such tissue growth such that an operator may selectivelyremove implant (700) from esophagus (2) if desired. Annular retainingassembly (710) includes a sufficient combination of inert materials andabsorbable materials promoting tissue growth to achieve both functions.

In particular, valve coupling annular body (712) and flanges (714, 716)are defined by an outer weave (720) filled with vertical column-likethreads (722). Internal annular sleeve (730) may be made out of an inertmaterial and extend within valve coupling annular body (712). Outerweave (720) may cover exterior portions of annular body (712) andflanges (714, 716) while vertical column-like threads (722) may fill aninterior portion of outer weave (720) to fill out annular body (712) andflanges (714, 716). Therefore, outer weave (720) has an exterior surfacefacing away from column-like threads (722) and an interior surface thatis adjacent to column-like threads (722). Outer weave (720) may be madeout of an absorbable material such that over a period of time afterdeployed within esophagus (2), outer wave (720) may dissolve.

Vertical column-like threads (722) may be made out of a material that isconfigured to promote a suitable amount of tissue growth such thatimplant (700) may remain stationary during operation, but also such thatimplant (700) may be removed from esophagus (2) when desired withoutcausing substantial damage. Of course, outer weave (720) and verticalcolumn-like threads (722) may both be made of absorbable material thatis configured to promote tissue growth such that after a suitable timedeployed within esophagus (2), tissue begins to grow around and/orreplace outer weave (720) and vertical column-like threads (722). Or,any other suitable combination of materials for outer weave (720) andvertical column-like threads (722) may be used as would be apparent toone having ordinary skill in the art in view of the teachings herein.Outer weave (720) and vertical column-like threads (722) may form afibrous absorbable lattice that may include both absorbable polymers andnon-absorbable polymers such as nylon and polypropylene.

The materials for valve coupling annular body (712) and flanges (714,716) can include bioabsorbable and biocompatible polymers, includinghomopolymers and copolymers. Non-limiting examples of homopolymers andcopolymers include p-dioxanone (PDO or PDS), polyglycolic acid (PGA),poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL),trimethylene carbonate (TMC), and polylactic acid (PLA), poly(glycolicacid-co-lactic acid) (PLA/PGA) (e.g., PLA/PGA materials used in Vicryl,Vicryl Rapide, PolySorb, and Biofix), polyurethanes (such as Elastane,Biospan, Tecoflex, Bionate, and Pellethane fibers), polyorthoesters,polyanhydrides (e.g., Gliadel and Biodel polymers), polyoxaesters,polyesteramides, and tyrosine-based polyesteramides. The copolymers canalso include polylactic acid-co-polycaprolactone) (PLA/PCL), poly(L-lactic acid-co-polycaprolactone) (PLLA/PCL), poly(glycolicacid-co-trimethylene carbonate) (PGA/TMC) (e.g., Maxon), Poly(glycolicacid-co-caprolactone) (PCL/PGA) (e.g., Monocryl and Capgly), PDS/PGA/TMC(e.g., Biosyn), PDS/PLA, PGA/PCL/TMC/PLA (e.g., Caprosyn), andLPLA/DLPLA (e.g., Optima). The polymers may also have medicants, suchexamples may also be further constructed and operable in accordance withat least some of the teachings of U.S. Pub. No. 2017/0055986, entitled“Medicant Eluting Adjuncts and Methods of Using Medicant ElutingAdjuncts,” published Mar. 2, 2017, the disclosure of which isincorporated by reference herein.

An outer edge of highly flexible silicone bag (755) may extend intoportions of outer weave (720) and vertical column-like threads (722)such that outer weave (720) and vertical column-like threads (722) areattached to highly flexible silicone bag (755) before outer weave (720)and vertical column-like threads (722) are absorbed. As shown in FIGS.17A-17B, outer weave (720) and vertical column-like threads (722) may beresiliently compressible such that outer weave (720) and column-likethreads (722) may deform in response to an external force and thenreturn to a natural shape. FIG. 17A shows the natural shape ofcolumn-like threads (722) while FIG. 17B shows column-like threads (722)in a compressed state.

Additionally, annular retaining assembly (710) includes a coiled suture(724) that is initially housed within valve coupling annular body (712).Coiled suture (724) may be made out of an inert material. Coiled suture(724) surrounds internal annular sleeve (730) such that coiled suture(724) may expand and contract with internal annular sleeve (730) inaccordance with the principles described above. Coiled suture (724) mayalso couple with highly flexible silicone base (755) via coupling means(726). Coiled suture (624) is configured to couple internal annularsleeve (730) and highly flexible silicone bag (755) after valve couplingannular flanges (712) and flanges (714, 716) are absorbed. Coiled suture(724) may sufficiently retard tissue growth around internal annularsleeve (730) and highly flexible silicone bag (755) such that when anoperator desires to remove implant (700) from esophagus (2), removal maylimit tissue damage around adjacent portions of esophagus (2).Therefore, coiled suture (724) may spatially fix internal annular sleeve(730) and highly flexible silicone bag (755) relative to each otherafter outer weave (720) and vertical column-like threads (722) areabsorbed. Additionally, coiled suture (724) may allow for annular sleeve(730) and highly flexible silicone bag (755) to be removed unitarilyfrom esophagus (2) after outer weave (720) and vertical column-likethreads (722) are absorbed.

FIGS. 18A-18B show an implanted annular retaining assembly (710) overvarious periods of time within esophagus (2). Additionally, anchors(718) extend from scaffold members (719) that act to fix a portion ofanchors (718) within vertical column-like threads (722). FIG. 18A showsannular retaining assembly (710) just after implantation. At this point,annular retaining assembly (710) is substantially spatially fixedrelative to esophagus (2) based on the holding strength of anchors(718). Additionally, absorbable material defining anchors (118), outerwave (720), and vertical column-like threads (722) are stillstructurally intact such that absorbable material has yet to break downand tissue growth has yet to occur.

After a suitable amount of time after implantation, as shown in FIG.18B, absorbable material defining anchors (718), outer wave (720), andvertical column-like threads (722) has broken down and been structurallyreplaced by tissue growth. Therefore, anchors (718) may no longer helpspatially fix annular retaining assembly (710) relative to esophagus(2). Non-absorbable structures such as internal annular sleeve (730) andcoiled suture (734) still remain intact. Spherical magnets (752) andspacing members (756) are still operable to space toward and away fromeach other to occlude esophagus (2). While tissue growth has replacedabsorbable material of anchors (718), outer weave (720), and verticalcolumn-like threads (722); implant (700) is sufficiently attached toesophagus (2) to remain substantially spatially fixed during operation.However, tissue growth has been suitably retarded due to non-absorbablestructures such as coiled suture (724) and internal annular sleeve(730). While a certain degree of tissue growth has been accomplished, itis suitably limited in case an operator wishes to remove implant (700).Therefore, an operator may apply enough force to implant (700), and/orincise tissue, to remove implant from esophagus (2) without damagingesophagus (2), if desired.

Valve coupling annular body (772), upper annular flange (714), lowerannular flange (716), anchors (718), coiled suture (724), outer weave(720), vertical column-like threads (722), internal annular sleeve(730), or any suitable combinations/portions therefore may include acoating or therapeutic substance. A coating may include an inertmaterial. The therapeutic substances may include an agent configured toheal tissue from a disease, defect, infection, inflammation, trauma, orany combination thereof. The therapeutic substances may include an agentconfigured to physically protect tissue from acidic compounds, such asagents that act to neutralize an acidic compound. The therapeuticsubstances may include a drug, a steroid, an antibiotic, or any othersuitable substance that would be apparent to one having ordinary skillin the art in view of the teachings herein. Non-limiting examples oftherapeutic substances may include antimicrobial agents, antifungalagents, anti-inflammatory agents, and growth factors. Non-limitingexamples of antimicrobial agents include Ionic Silver, Triclosan,Tetracyclines, Doxycycline, Minocycline, Demeclocycline, Tetracycline,Oxytetracycline, Gentamicin, Neomycin, Non-limiting examples ofantifungal and antimicrobial agents include Triclosan, Triazole,Thiazole, LAE, Sodium Stearate, Non-limiting examples ofanti-inflammatory agents include non-steroidal anti-inflammatory agents(e.g., Salicylates, Aspirin, Diflunisal, Propionic Acid Derivatives,Ibuprofen, Naproxen, Fenoprofen, and Loxoprofen), acetic acidderivatives (e.g., Tolmetin, Sulindac, and Diclofenac), enolic acidderivatives (e.g., Piroxicam, Meloxicam, Droxicam, and Lornoxicam),anthranilic acid derivatives (e.g., Mefenamic Acid, Meclofenamic Acid,and Flufenamic Acid), selective COX-2 inhibitors (e.g., Celecoxib(Celebrex), Parecoxib, Rofecoxib (Vioxx), Sulfonanilides, Nimesulide,and Clonixin), immune selective anti-inflammatory derivatives,corticosteroids (e.g., Dexamethasone), and iNOS inhibitors, Non-limitingexamples of growth factors include those that are cell signalingmolecules that stimulate cell growth, healing, remodeling,proliferation, and differentiation. Exemplary growth factors can beshort-ranged (paracrine), long ranged (endocrine), or self-stimulating(autocrine). Further examples of the growth factors include growthhormones (e.g., a recombinant growth factor, Nutropin, Humatrope,Genotropin, Norditropin, Saizen, Omnitrope, and a biosynthetic growthfactor), Epidermal Growth Factor (EGF) (e.g., inhibitors, Gefitinib,Erlotinib, Afatinib, and Cetuximab), heparin-binding EGF like growthfactors (e.g., Epiregulin, Betacellulin, Amphiregulin, and Epigen),Transforming Growth Factor alpha (TGF-a), Neuroregulin 1-4, FibroblastGrowth Factors (FGFs) (e.g., FGF1-2, FGF2, FGF11-14, FGF18, FGF15/19,FGF21, FGF23, FGF7 or Keratinocyte Growth Factor (KGF), FGF10 or KGF2,and Phenytoin), Insuline-like Growth Factors (IGFs) (e.g., IGF-1, IGF-2,and Platelet Derived Growth Factor (PDGF)), Vascular Endothelial GrowthFactors (VEGFs) (e.g., inhibitors, Bevacizumab, Ranibizumab, VEGF-A,VEGF-B, VEGF-C, VEGF-D and Becaplermin). The therapeutic substances mayalso include other medicants, such examples may also be furtherconstructed and operable in accordance with at least some of theteachings of U.S. Pub. No. 2017/0055986, entitled “Medicant ElutingAdjuncts and Methods of Using Medicant Eluting Adjuncts,” published Mar.2, 2017, the disclosure of which is incorporated by reference herein.

Additionally, therapeutic substances may be embedded in a hollow area,such as a porous portion, of valve coupling annular body (712), upperannular flange (714), lower annular flange (716), anchors (718), coiledsuture (724), outer weave (720), vertical column-like threads (722), orinternal annular sleeve (730). Therapeutic substances may be configuredto elute from a portion of the artificial sphincter into the tissue ofthe biological passageway.

VII. EXEMPLARY COMBINATIONS

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

An apparatus configured to be implanted within a biological structure,the apparatus comprising: (a) a plurality of magnetic elements, whereinthe magnetic elements are arranged in an annular array extending from anaxis, wherein the annular array defines an occludable opening configuredto transition between occluded state and an opened state, wherein themagnetic elements comprise: (i) a first magnetic element, and (ii) asecond magnetic element located adjacent to the first magnetic element,wherein the second magnetic element comprises a polymer magneticmaterial, wherein the polymer magnetic material is formed in a shapedesigned to geometrically interlock with the first magnetic element inthe occluded state, wherein the second magnetic element is configured toelastically deform to transition the occludable opening from theoccluded state to the opened state; and (b) a coupling body configuredto affix to a portion of the first magnetic element and a portion of thesecond magnetic element.

Example 2

The apparatus of Example 1, wherein the first magnetic element and thesecond magnetic element are magnetically biased toward the occludedstate.

Example 3

The apparatus of any one or more of Examples 1 through 2, wherein thefirst magnetic element also comprises the polymer magnetic material.

Example 4

The apparatus of any one or more of Examples 1 through 3, wherein thefirst magnetic element and the second magnetic element are configured tooverlap with each other in the occluded state.

Example 5

The apparatus of any one or more of Examples 1 through 4, wherein thecoupling body comprises a plurality of anchors configured to engage thebiological lumen.

Example 6

The apparatus of Example 5, wherein the anchors comprise a plurality ofbarbs.

Example 7

The apparatus of any one or more of Examples 1 through 6, wherein thesecond magnetic element comprises a circumferential perimeter portionand a radial perimeter portion, wherein the circumferential perimeterportion is attached to the coupling body, wherein the radial perimeterportion extends from the circumferential perimeter portion toward theaxis.

Example 8

The apparatus of Example 7, wherein the radial perimeter portion of thesecond magnetic element is configured to geometrically interlock withthe first magnetic element in the occluded state.

Example 9

The apparatus of any one or more of Examples 7 through 8, wherein theradial perimeter portion terminates into a central tip.

Example 10

The apparatus of any one or more of Examples 7 through 8, wherein theradial perimeter portion terminates into an arcuate portion.

Example 11

The apparatus of any one or more of Examples 1 through 10, wherein thecoupling body comprises a therapeutic substance.

Example 12

The apparatus of any one or more of Examples 1 through 11, wherein thesecond magnetic element comprises a non-absorbable plastic coating.

Example 13

The apparatus of any one or more of Examples 1 through 12, wherein thesecond magnetic element comprises a high-coercivity ferromagneticcompound.

Example 14

The apparatus of any one or more of Examples 1 through 13, wherein thecoupling body comprises a non-absorbable material and an absorbablematerial configured to promote tissue growth.

Example 15

The apparatus of any one or more of Examples 1 through 14, wherein thecoupling body is dimensioned to be inserted within an esophagus tothereby abut against the esophagus.

Example 16

An apparatus configured to be implanted within a biological structure,the apparatus comprising: (a) a plurality of elastically deformablemagnets arranged in an annular array, wherein the plurality ofelastically deformable magnets define an occludable opening configuredto transition between an occluded state and an opened state, wherein theelastically deformable magnets are magnetically biased toward theoccluded state; (b) a connecting structure, wherein the connectingstructure interconnects the elastically deformable magnets together toprevent each of the elastically deformable magnets from disconnectingfrom the rest of the elastically deformable magnets; and (c) an inertstructure, wherein the inert structure comprises a coating or extrusionsof a polymer that is configured to limit erosion of the apparatusthrough the biological structure.

Example 17

The apparatus of Element 16, wherein the connecting structure defines aplurality of notches configured to promote flexibility of the connectingstructure

Example 18

The apparatus of any one or more of Examples 16 through 17, wherein theinert structure surrounds the connecting structure.

Example 19

An apparatus configured to be implanted within a biological structure,the apparatus comprising: (a) a plurality of magnetic elements, whereinthe magnetic elements are arranged in an annular array extending aboutan axis, wherein the annular array defines an occludable openingconfigured to transition between occluded state and an opened state,wherein the plurality of magnetic elements are magnetically attractedtoward the occluded state; and (b) a coupling body configured to affixto the plurality of magnetic elements, wherein the coupling body isdimensioned to abut against the biological structure.

Example 20

The apparatus of Example 19, wherein the coupling body comprises anadhesive configured to temporarily attach the coupling body to thebiological structure.

VIII. MISCELLANEOUS

It should also be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

The teachings herein may be readily combined with the teachings of U.S.Pat. No. 7,175,589, the disclosure of which is incorporated by referenceherein; U.S. Pat. No. 7,695,427, the disclosure of which is incorporatedby reference herein; U.S. Pat. No. 8,070,670, the disclosure of which isincorporated by reference herein; and/or U.S. Pat. No. 8,734,475, thedisclosure of which is incorporated by reference herein. Varioussuitable ways in which the teachings herein may be combined with theteachings of one or more of the above-cited references will be apparentto those of ordinary skill in the art.

In the examples described herein that include fibrous constructions,absorbable materials, and/or drug eluting capabilities, such examplesmay further be constructed and operable in accordance with at least someof the teachings of U.S. Pub. No. 2015/0134077, entitled “SealingMaterials for Use in Surgical Stapling,” published May 14, 2015, thedisclosure of which is incorporated by reference herein. For instance,the teachings of one or more of paragraphs [0103]-[0105], [0110]-[0111],and/or [0127] of U.S. Pub. No. 2015/0134077 may be readily combined withthe teachings herein in numerous ways as will be apparent to those ofordinary skill in the art.

In the examples described herein that include absorbable materialsand/or drug eluting capabilities, such examples may also be furtherconstructed and operable in accordance with at least some of theteachings of U.S. Pub. No. 2017/0055986, entitled “Medicant ElutingAdjuncts and Methods of Using Medicant Eluting Adjuncts,” published Mar.2, 2017, the disclosure of which is incorporated by reference herein.For instance, the teachings of one or more of paragraphs [0389] and/or[0392]-[0402] of U.S. Pub. No. 2017/0055986 may be readily combined withthe teachings herein in numerous ways as will be apparent to those ofordinary skill in the art.

In the examples described herein that include compressible wovenconstructs, such examples may further be constructed and operable inaccordance with at least some of the teachings of U.S. Pub. No.2017/0086837, entitled “Compressible Adjunct with Crossing SpacerFibers,” published Mar. 30, 2017, the disclosure of which isincorporated by reference herein. For instance, the teachings of one ormore of paragraphs [0216]-[0244] may be readily combined with theteachings herein in numerous ways as will be apparent to those ofordinary skill in the art.

In the examples described herein that include absorbable materialsand/or materials that promote or discourage tissue in-growth, suchexamples may further be constructed and operable in accordance with atleast some of the teachings of U.S. Pub. No. 2015/0129634, entitled“Tissue Ingrowth Materials and Method of Using the Same,” published May14, 2015, the disclosure of which is incorporated by reference herein.For instance, the teachings of one or more of paragraphs [0082]-[0096]of U.S. Pub. No. 2015/0129634 may be readily combined with the teachingsherein in numerous ways as will be apparent to those of ordinary skillin the art.

In the examples described herein that include absorbable materialsand/or materials that promote tissue in-growth, such examples mayfurther be constructed and operable in accordance with at least some ofthe teachings of U.S. Pub. No. 2015/0133996, entitled “PositivelyCharged Implantable Materials and Method of Forming the Same,” publishedMay 14, 2015, the disclosure of which is incorporated by referenceherein. For instance, the teachings of one or more of paragraphs[0067]-[0079] of U.S. Pub. No. 2015/0133996 may be readily combined withthe teachings herein in numerous ways as will be apparent to those ofordinary skill in the art.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

The teachings presented herein may be further combined with variousteachings of any one or more of the following: U.S. application Ser. No.15/664,464, entitled “An Absorbable Polymer for a Magnetic SphincterAssist Device,” filed on Jul. 31, 2017, published as U.S. Pub. No.2019/0029794 on Jan. 31, 2019, the disclosure of which is incorporatedby reference herein; U.S. application Ser. No. 15/664,514, entitled “AnAbsorbable Polymer with Drug Elution for a Magnet Sphincter AssistDevice,” filed on Jul. 31, 2017, published as U.S. Pub. No. 2019/0029800on Jan. 31, 2019, the disclosure of which is incorporated by referenceherein; U.S. application Ser. No. 15/664,566, entitled “Magnet RestraintMechanism for a Sphincter Assist Device,” filed on Jul. 31, 2017,published as U.S. Pub. No. 2019/0029688 on Jan. 31, 2019 the disclosureof which is incorporated by reference herein; U.S. application Ser. No.15/664,665, entitled “Method for Assisting a Sphincter,” filed on Jul.31, 2017, issued as U.S. Pat. No. 10,105,865 on Sep. 10, 2019, thedisclosure of which is incorporated by reference herein; and/or otherpatents and patent application publications incorporated by referenceabove.

We claim:
 1. An apparatus configured to be implanted within a biologicalstructure, the apparatus comprising: (a) a plurality of magneticelements, wherein the magnetic elements are arranged in an annular arrayextending from an axis, wherein the annular array defines an occludableopening configured to transition between an occluded state and an openedstate, wherein the magnetic elements comprise: (i) a first magneticelement, and (ii) a second magnetic element located adjacent to thefirst magnetic element, wherein the second magnetic element comprises apolymer magnetic material, wherein the polymer magnetic material isformed in a shape designed to geometrically interlock with the firstmagnetic element in the occluded state to form an internal seal, whereinthe second magnetic element is configured to elastically deform totransition the occludable opening from the occluded state to the openedstate; and (b) a coupling body configured to affix to a portion of thefirst magnetic element and a portion of the second magnetic element. 2.The apparatus of claim 1, wherein the first magnetic element and thesecond magnetic element are magnetically biased toward the occludedstate.
 3. The apparatus of claim 1, wherein the first magnetic elementalso comprises the polymer magnetic material.
 4. The apparatus of claim1, wherein the first magnetic element and the second magnetic elementare configured to overlap with each other in the occluded state.
 5. Theapparatus of claim 1, wherein the coupling body comprises a plurality ofanchors configured to engage the biological lumen.
 6. The apparatus ofclaim 5, wherein the anchors comprise a plurality of barbs.
 7. Theapparatus of claim 1, wherein the second magnetic element comprises acircumferential perimeter portion and a radial perimeter portion,wherein the circumferential perimeter portion is attached to thecoupling body, wherein the radial perimeter portion extends from thecircumferential perimeter portion toward the axis.
 8. The apparatus ofclaim 7, wherein the radial perimeter portion of the second magneticelement is configured to geometrically interlock with the first magneticelement in the occluded state.
 9. The apparatus of claim 7, wherein theradial perimeter portion terminates into a central tip.
 10. Theapparatus of claim 7, wherein the radial perimeter portion terminatesinto an arcuate portion.
 11. The apparatus of claim 1, wherein thecoupling body comprises a therapeutic substance.
 12. The apparatus ofclaim 1, wherein the second magnetic element comprises a non-absorbableplastic coating.
 13. The apparatus of claim 1, wherein the secondmagnetic element comprises a high-coercivity ferromagnetic compound. 14.The apparatus of claim 1, wherein the coupling body comprises anon-absorbable material and an absorbable material configured to promotetissue growth.
 15. The apparatus of claim 1, wherein the coupling bodyis dimensioned to be inserted within an esophagus to thereby abutagainst the esophagus.
 16. An apparatus configured to be implantedwithin a biological structure, the apparatus comprising: (a) a pluralityof magnetic elements, wherein the magnetic elements are arranged in anannular array extending from an axis, wherein the annular array definesan occludable opening configured to transition between an occluded stateand an opened state, wherein the magnetic elements comprise: (i) a firstmagnetic element, and (ii) a second magnetic element located adjacent tothe first magnetic element, wherein the second magnetic elementcomprises a polymer magnetic material, wherein the polymer magneticmaterial is formed in a shape designed to geometrically interlock withthe first magnetic element in the occluded state, wherein the secondmagnetic element is configured to elastically deform to transition theoccludable opening from the occluded state to the opened state; and (b)a coupling body configured to affix to a portion of the first magneticelement and a portion of the second magnetic element, wherein thecoupling body is configured to attach to an internal surface of thebiological structure such that the plurality of magnetic elements formsan internal seal.
 17. The apparatus of claim 16, wherein the couplingbody comprises an inert material.
 18. The apparatus of claim 17, whereinthe inert material forms a coiled structure.
 19. An apparatus configuredto be implanted within a biological structure, the apparatus comprising:(a) a plurality of magnetic elements, wherein the magnetic elements arearranged in an annular array extending from an axis, wherein themagnetic elements are configured to be housed within an internal lumenof the biological structure when the apparatus is implanted within thebiological structure, wherein the annular array forms an internal sealthat defines an occludable opening configured to transition between anoccluded state and an opened state, wherein the magnetic elementscomprise: (i) a first magnetic element, and (ii) a second magneticelement located adjacent to the first magnetic element, wherein thesecond magnetic element comprises a polymer magnetic material, whereinthe polymer magnetic material is formed in a shape designed togeometrically interlock with the first magnetic element in the occludedstate, wherein the second magnetic element is configured to elasticallydeform to transition the occludable opening from the occluded state tothe opened state; and (b) a coupling body configured to affix to aportion of the first magnetic element and a portion of the secondmagnetic element.